Biogen Idec Inc.
Form 483 issued February 15, 2019 · Morrisville, North Carolina
- Inspection
- Feb 7, 2018 – Feb 15, 2019
- Investigator
- Cynthia Jim
- Observations
- 5
- Pages
- 4
- FEI number
- 3000719749
In short: On February 15, 2019, FDA issued a Form 483 with 5 observations to Biogen Idec Inc. in Morrisville, North Carolina (FEI 3000719749) after an inspection that ran Feb 7, 2018 – Feb 15, 2019. The investigator was Cynthia Jim. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review unexplained discrepancy and/or the failure of a batch or…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
The review of equipment log books have failed to capture testing…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmBiogen Idec Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biogen Idec Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Biogen Idec Inc.?
Cynthia Jim is named on this Form 483, for the inspection of Feb 7, 2018 – Feb 15, 2019. Each investigator has a profile showing what they cite most.
When was Biogen Idec Inc. inspected by FDA?
The inspection ran Feb 7, 2018 – Feb 15, 2019, and the Form 483 is dated February 15, 2019.
How do I get the full Form 483 for Biogen Idec Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.